Current practices of drug dissolution testing using paddle and basket spindles face many hurdles in obtaining relevant and reproducible results. These difficulties are result of poor product-medium interactions. In addition, significant concerns have been reported in the literature regarding the lack of ruggedness in the operation of the apparatuses, such as potential sensitivities to vibration, air/gases content in media, positions of product in vessels, uneven mixing patterns, variation in vessel dimension even within specifications.

A newly developed spindle (as shown), known as crescent-shaped, which can easily be installed in the vessel-based dissolution apparatuses (basket and paddle) to provide a product-independent dissolution testing approach for improved drug dissolution assessments. The new spindle provides an improved stirring and mixing environment, leading to better characterization of pharmaceutical products.

The use of the crescent-shaped spindles offers additional significant advantages over the current practices, such as: (1) allows analyses using a single method, compared to hundreds as currently required, for both immediate and extended-released products having the same or different active ingredients; (2) provides improved dissolution characteristics of products by avoiding false slow release properties for fast release type products; (3) simplifies testing by avoiding the necessity of developing separate QC and bio-relevant dissolution methods; (4) provides a rugged testing environment free from common sensitivities, in particular to de-aeration and vibration effects.

If you like to have further information, reported in the literature as well, describing the applications and benefits of using the crescent-shaped spindle, please email to moderator.